This pragmatic RCT (2019–2024, 18-month follow-up) compared enhanced standard of care plus family-based behavioral treatment (ESOC+FBT) vs. ESOC alone in 730 children aged 6–15 years with obesity across 41 primary care practices in 4 US states, including a socioeconomically diverse sample (47% Medicaid, 22% food insecure).
At 12 months, ESOC+FBT reduced percent median BMI by **−6.4 units** (95% CI, −8.29 to −4.43) vs. **−2.6 units** for ESOC alone (95% CI, −4.46 to −0.71); mean between-group difference of **−3.8 units** (95% CI, −6.20 to −1.34; P = .002). Weight-associated quality of life also improved more with ESOC+FBT (difference: 2.0 units; 95% CI, 0.05–4.00). No adverse events were related to trial participation.
- High pre-randomization exclusion/decline rate (901 of 1,631 screened families), which may limit generalizability. - Full text was not available for review; publisher page was security-blocked, so secondary outcomes and subgroup analyses could not be fully assessed. - Open-label design for participants and clinicians (only data collectors were blinded), introducing potential performance bias.
Adding structured family-based behavioral treatment to primary care-led obesity management produces meaningfully greater BMI reduction in children and adolescents than enhanced standard care alone. Clinicians at primary care practices should consider integrating FBT interventionists into pediatric obesity workflows, particularly for diverse and underserved populations.
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